Risk Evaluation and Mitigation Strategy Programs to Promote Appropriate Medication Use and Knowledge: Physician Interviews on Experiences with REMS Programs (CDER)

Methodological Approaches to Evaluate the Impact of Risk Evaluation and Mitigation Strategy (REMS) Programs: Physician Experiences with REMS Programs

Recruitment Message

Professional Group Outreach

Dear [Professional Group Name],

I am a faculty member at Harvard Medical School and Brigham and Women’s Hospital, and I am conducting research on Risk Evaluation and Mitigation Strategy (REMS) programs, which the Food and Drug Administration (FDA) requires manufacturers of certain medications to implement. My project team and I are seeking to better understand the benefits and burdens of REMS programs on patient care. Our work is being conducted on behalf of the FDA and does not involve any pharmaceutical companies.

I am requesting your help to invite physicians who have prescribed [drug name]—a REMS program-covered drug—in the last year to participate in a 60-minute phone interview about their experiences. If you are happy to assist, I ask that you please forward the attached invitation message and consent form to your membership list.

If you have any questions or would like to discuss the study in more depth, please contact me at [email protected]. Thank you very much for your help on this important investigation.

Best,

Ameet Sarpatwari, Ph.D., J.D.

Assistant Professor of Medicine at Harvard Medical School

Division of Pharmacoepidemiology and Pharmacoeconomics

Brigham and Women's Hospital

1620 Tremont St, Suite 3030

Boston MA 02120

[email protected]